SCOPE of PRACTICE for HUMAN RESEARCH Lexington VAMC (#596) R&D (151)

SCOPE OF PRACTICE FOR HUMAN RESEARCH Lexington VAMC (#596) R&D (151)

Name / Job Title
Licensure / Degree
☐ None
☐ Describe: ______/ ☐ MD, ☐ DO, ☐PhD, ☐ PharmD, ☐NP/CNS,
☐ PA, ☐ BS, ☐ MS, ☐ LPN, ☐ None
☐ Other: ______
Principal Investigator (PI):

The Scope of Practice is specific to the duties and responsibilities of each research employee/staff who are not otherwise credentialed and privileged (through Quality Systems) or who have functional statements at Lexington VA Medical Center. The research employee/staff serves as an agent of the listed Principal Investigator(s) and their scope of practice is to be reviewed biannually. The employee is specifically authorized to provide assistance in research involving human subjects with the responsibilities approved below in conjunction with approved research protocols. The Principal Investigator remains responsible at all times for the conduct of the employee and must complete, sign and date this Scope of Practice.

Procedures

An employee may be authorized to perform the following duties and procedures on a regular and ongoing basis under protocols approved by the Lexington VAMC IRB and R&D Committee. The original signed document will be maintained by the PI. One copy will be maintained in the Research Office. Check the appropriate boxes for routine duties that apply to the research employee.

Routine Duties (may require competencies or credentials)
☐ Prepares regulatory documents for Lexington VAMC IRB and R&D Committee
☐ Develops and/or implements recruitment methods to be utilized in the study and recruits subjects as specified per approved protocol
☐ Prepares study initiation program, materials and activities
☐ Screens patients to determine study eligibility criteria by reviewing patient medical information or interviewing patients (requires competency verification by observation by PI to include attendance at study meeting and/or detailed review with the PI regarding protocol)
☐ Maintains screening logs (requires current Privacy and Information Security Training)
☐ Provides education regarding study activities to patient, relatives and Medical Center staff as necessary per protocol (requires competency verification by observation by PI)
☐ Obtains Informed Consent and HIPAA Authorization (requires competency verification by observation by PI)
☐ Obtains information from subject pertinent to research protocol (requires competency verification by observation by PI)
☐ Reports laboratory results and other diagnostic (i.e. radiography, clinical pathology, etc.) to study sponsor and appropriate personnel in a timely manner
☐ Schedules participant research visits and study procedures
☐ Enters research progress notes into CPRS under appropriate headings and titles
☐ Obtains and organizes data such as tests results, diary/cards or other necessary information for this study
☐ Maintain complete and accurate records: including data collection records, source documents and case report forms
☐ Prepares vouchers for participant payment (must comply with IRB-approved schedule)
☐ Drug Accountability: Provides oral study medication from pharmacist, after order by licensed provider to participant (requires competency verification by observation by PI, and dispensing agreement with research pharmacist)
☐ Provides participant education and instruction on use of study medication, including administration, storage, side effects and how to notify research of adverse drug reactions (competency verified by observation by PI)
☐ Establishes intravenous (IV) access (limited by license and scope of practice within Lexington VAMC and competency verified by the PI)
☐ Administers intravenous (IV) solutions and medications (limited by license and scope of practice within Lexington VAMC and competency verified by the PI)
☐ Checks and records vital signs (requires competency verification by observation by PI for non-licensed staff)
☐ Performs physical examination (within scope of license)
☐ Evaluates acute health problems, including possible adverse events (within limits of license)
☐ Performs physical assessment (for RN's and other licensed individuals within limits of license)
☐ Performs venipuncture to obtain specific specimens required by study protocol (history and documentation of previous training and competency verification by observation by PI)
☐ Processes human specimens per protocol including blood, urine, sputum, buccal swabs, etc. (requires competency verification by observation by PI to include VA appropriate Infection control training)
☐ Ships biological specimens/materials (complete required “shipping and packing training
☐ Initiates orders for diagnostic testing including laboratory processing of samples, x-rays, etc. as outlined in the research protocol- subject to final approval and signature of responsible PI prior to completion
☐ Reports laboratory results and other diagnostic (i.e. radiography, clinical pathology, etc.) to study sponsor and appropriate personnel in a timely manner
☐ Additional Duties: (Note: Clinical procedures that routinely require informed consent at Lexington VAMC, even if performed for research purposes, may only be performed by a Licensed Independent Practitioner
☐ Utilizes human specimen/tissue for laboratory research
☐ Retrospective Chart review
☐
☐

Notice to Licensed Professionals:

Individuals found to be working outside their privileges as granted by Lexington VAMC will be subject to disciplinary action and possible reporting to the National Practitioner Data Bank.

This Scope of Practice outlines general tasks I am permitted to undertake in conjunction with an approved research protocol. I understand that all human studies research must be approved by the Lexington VAMC R&D through the IRB committee. If I have any questions or concerns, I am encouraged to contact the Lexington VAMC Research and Development Office. I understand that performing tasks beyond this Scope of Practice, without specific authorization, may lead to disciplinary action. Both the Principal Investigator and I are familiar with all duties and procedures granted in this Scope of Practice and all applicable hospital policies and regulations.

ANY CHANGES TO THIS SCOPE OF PRACTICE WILL BE SUBMITTED FOR APPROVAL PRIOR

TO THE ADDITION OF NEW DUTIES.

Principal Investigator's Printed Name Principal Investigator's Signature Date

Additional Supervisor’s Printed Name Additional Supervisor’s Signature Date

Additional Supervisor’s Printed Name Additional Supervisor’s Signature Date

OFFICE USE ONLY

Review Date: ______

Signature, ACOS for Research and Development

06-24-2016 Scope of Practice for Human Research at the Lexington VAMC